Science Symposium Addresses New EPA Reporting Requirements for Nanomaterials

By Ed Rutkowski

Salt Palace Convention Center, Salt Lake City (June 2, 2015)—At a special symposium on nanotechnology held yesterday at AIHce , Lynn Bergeson, a prominent DC-based attorney, argued that recent regulatory developments affecting the nanotechnology industry would ultimately help manufacturers convince the public that their products are safe to use.

Bergeson is owner and principal of Bergeson & Campbell PC, a firm that specializes in helping companies meet regulatory and compliance requirements to get their products to market. Her presentation discussed the implications for nanotechnology from regulations such as the Toxic Substances Control Act (TSCA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and the European Union’s Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) legislation.

In April, EPA proposed using its authority under TSCA to collect exposure and health and safety information on nanoscale chemical substances already in use in the marketplace. The agency currently reviews new chemical substances that are manufactured or processed as nanomaterials for safety prior to their introduction into the marketplace. According to EPA, the proposed requirements would facilitate the agency’s evaluation of these materials. Comments on the proposal are due July 6.

EPA’s action has sparked complaints from the nanotechnology industry about the rule’s complexity. Bergeson acknowledged the legitimacy of these concerns but argued that the proposed rule would ultimately benefit manufacturers, importers, and others in the nanotechnology industry by helping convince the public that nanomaterials can be used safely.

“I think this is huge,” Bergeson said of the EPA proposal, adding that it will result in a “bonus dose of information [about nanomaterials] that is credible and will inform EPA’s risk assessment judgments.”

Some of industry’s concerns about EPA’s proposal are related to questions surrounding reporting requirements, Bergeson said. For example, in manufacturing, it can be difficult to determine when a nanoscale material has been altered sufficiently to form a new chemical substance, which would require the manufacturer to submit separate information to EPA.

“What is a discreet form of a nanoscale material? What degree of variation will require a separate submission? It’s not always clear,” Bergeson said.

Another development that has significant potential to affect nanomaterials manufacturers is the growing popularity of product registries, particularly in the EU. Although no EU-wide disclosure requirement exists, the member states are developing their own requirements, Bergeson said. In many cases, products containing nanomaterials are required to be posted on a public registry. Bergeson speculated that the growth of these registries could ultimately force labeling requirements that would have significant potential to affect the way companies market their products in other jurisdictions.

Greater sharing of such information with governments also has the potential to cause companies’ insurance rates to rise, Bergeson said. Still, she interprets these developments as ultimately beneficial to the nanotechnology industry, which has an interest in ensuring that any government restrictions placed on the industry are based on credible, accurate information.

“Governance frameworks are always out of date,” Bergeson said. “They can never keep up with the speed of innovation. We want people to know what they're dealing with [so they] have a solid basis to make informed judgments about risk.”

Ed Rutkowski is editor in chief of The Synergist. He can be reached at (703) 846-0734.

View more Synergist coverage of the conference on the AIHce 2015 Highlights page.